Medical Devices
In Europe, the type of product for which you are seeking CE Mark is addressed by regulations agreed upon by each of the Member States known as Directives. The three general directives affecting medical devices in Europe are:
AIMD Active Implantable Medical Device Directive Implanted defibrillators, drug delivery systems, pacemakers, etc.
IVDD In Vitro Diagnostic Directive IVD reagents, controls, calibrators, systems
MDD Medical Devices Directive All other medical devices
Compliance with AIMD and many times with MDD or IVDD requires proof of product requirements conformity plus quality systems certification by a 3rd party assessment agency known as a Notified Body. What determines whether or not such certification is required is the level of risk of the products. In addition to Quality Systems (ISO 13485) certification, product related requirements may be subject to review by a Notified Body, or the company may be required to comply on "their own".
Other Directives
The EU has issued several follow-on directives which impact the Medical Device, IVD, and Biotech industries. These include:
ATD Animal Tissue Directive Medical devices made from animal materials, ie: collagen
HTD Human Tissue Directive Medical devices made from autologous human materials
ROHS Restriction of Hazardous Substances Products with heavy metals and other toxic materials
WEEE Waste Electrical & Electronic Equipment Recyclability of electrical and electronic materials
As a minimum, if any of these other directives apply, a file must be prepared demonstrating conformity with the terms of the directive, as well as any harmonized standards which have been recognized for use with the directive. In addition, an official party representing your firm in Europe, known as an Authorized Representative must be under contract and hold the file on your behalf in the event one of the national inspectors wishes to review it, as in the case after a mishap or accident.
Technical Files/Design Dossiers
The CRO Group can help you prepare the technical files required for CE Marking for all products. By using one of our three programs, it is assured that the technical files will be prepared the way your Notified Body expects, including all the checklists, summaries, and support information.
Technical files generally include Declarations of Conformity and certifications of test compliance from accredited agencies such as UL, CSA, TUV, etc. For a general explanation of the types of testing involved, click here.
Authorised Representative services
The CRO Group is an Authorized Representative in Europe. For medical device and IVD companies without an office in Europe, this is an absolute must for CE Marking. For a quote, click here.